Personalized Risk Assessment of Seizures Sensitive to Poor Sleep: a Longitudinal Study Using Wearable Electroencephalography Devices
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Epilepsy Intractable
- Sponsor
- Duke University
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Spike rates per hour (epilepsy marker)
- Status
- Not yet recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
Epilepsy, a prevalent neurological disorder, affects 40% of patients with uncontrolled seizures despite medications. Sleep disturbance exacerbates epilepsy, and vice versa, but existing literature suffers from limitations. Studies conducted in hospital settings provide only brief observation periods and fail to capture the natural sleep environment. Wearable technology offers a promising solution, providing a nuanced understanding of the relationship between seizures and sleep. The Dreem headband, an EEG-based wearable, is well-suited for such studies, offering ease of use and validated accuracy. This technology enables extended observation periods under stable medication conditions, essential for assessing the complex interplay between sleep and epilepsy. By elucidating the impact of sleep on seizures, the researchers seek to identify patient populations where sleep significantly influences seizure susceptibility, ultimately informing personalized epilepsy treatments.
Detailed Description
The first aim of this study is to investigate how variations in sleep timing, duration, and structure influence seizure risk, particularly in individuals with sleep-sensitive seizures. The investigators will conduct longitudinal EEG assessments to analyze how changes in sleep features correlate with interictal epileptiform discharge rates and seizure occurrences over time. The second aim is to develop a sleep quality index that predicts individual risk for sleep-sensitive seizures, the Sleep-Sensitive Epilepsy Risk Index (SERI). This index aims to predict an individual's seizure risk associated with disrupted sleep, facilitating personalized and preventative patient care.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \> 18 years
- •At least 2 seizures per week based on clinical notes
- •Patients where medications will stay stable over the study period
- •40% of both spikes and spindles are identifiable on the dreem headband based on the screening night
Exclusion Criteria
- •Cognitive impairment
- •Psychiatric comorbidities which may influence sleep
- •No bedpartner/caregiver to observe seizures
- •Low agreement (below 60%) between Dreem's sleep scoring and manual scoring will be excluded from the study
- •Apnea-hypopnea index of \> 10/h
Outcomes
Primary Outcomes
Spike rates per hour (epilepsy marker)
Time Frame: 21 days
Spikes will be detected by the Dreem headband
Total sleep time (sleep macrostructure)
Time Frame: 21 days
Total sleep time as measured by the Dreem headband
Seizure frequency per night (epilepsy marker)
Time Frame: 21 days
Seizures will be detected by the Dreem headband
Secondary Outcomes
- Sleep latency (sleep macrostructure)(21 days)
- Sleep efficiency (sleep macrostructure)(21 days)
- Sleep stage distribution (sleep macrostructure)(21 days)
- Sleep spindle events (sleep microstructure)(21 days)
- Sleep slow wave events (sleep microstructure)(21 days)
- Performance the SERI model, as measured by the area under the receiver operating characteristic curve(Up to 2 years after study commencement)
- Wake after sleep onset (sleep macrostructure)(21 days)
- Specificity of the SERI model(Up to 2 years after study commencement)
- Performance the SERI model, as measured by F1-score(Up to 2 years after study commencement)
- Sensitivity of the SERI model(Up to 2 years after study commencement)